Adjunctive Colchicine's Effect on Inflammatory Markers and Corresponding New-Onset Atrial Fibrillation Rates Post Coronary Artery Bypass Graft Procedure: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Inflammatory markers
研究概览
简要总结
This study wants to see if the medicine colchicine can help lower inflammation and reduce the chance of developing an irregular heartbeat (atrial fibrillation) after heart bypass surgery. Adults having coronary artery bypass surgery (CABG) can join. Participants will be randomly placed into one of two groups: one group will receive colchicine along with usual care, and the other will receive a placebo (a look-alike capsule with no medicine) along with usual care. Everyone will take a study capsule, and neither the patients nor the study team will know which capsule is being given. Everyone in the study will take study capsule, and neither the patients nor the study team will know who is receiving colchicine or placebo. Blood samples and health information will be collected before surgery; at 24, 48, 72, and 96 hours after surgery; and again at 10 days after surgery or at hospital discharge, whichever comes first. The investigators will look at inflammation marker levels, whether atrial fibrillation happens, and any side effects. This small study will help to generate effect size estimates and safety data that will help plan a larger study in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •Coronary artery bypass graft (CABG) planned procedure
排除标准
- •History of atrial fibrillation
- •Off-pump CABG procedure
- •Current treatment with colchicine for any cause
- •Hypersensitivity to colchicine (as indicated by rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever)
- •Emergency cardiac surgery
- •Extracorporeal Membrane Oxygenation (ECMO) pre- or post-cardiac surgery
- •Heart transplant patients
- •Left ventricular assist device (LVAD) patients
- •Serum creatinine >2.0 mg/dL
- •Preoperative elevated CK or known myopathy
- •Severe liver disease or elevation of serum transaminases (>1.5 times the upper limit of 40 units/liter)
- •Chronic intestinal disease or blood dyscrasia
- •Unable to speak English
- •Pregnancy or lactation in women
研究组 & 干预措施
Standard of care and placebo
placebo capsule
干预措施: Placebo (Drug)
Standard of care and colchicine
colchicine capsule
干预措施: Colchicine (Colcrys®) (Drug)
结局指标
主要结局
Change in Inflammatory markers
时间窗: Baseline (pre-surgery), 24, 48, 72, 96 hours post-surgery and 10 days postoperatively or at discharge, whichever occurs first.
markers of inflammation (IL-6, CRP, IL-18, IL-1β, IL-8, and TNF-α) will be measured at predefined time points. Blood samples will be obtained as part of routine clinical care and analyzed using commercially available ELISA assays.
Rate of post-operative atrial fibrillation (POAF)
时间窗: Through discharge (up to 15 days)
Postoperative atrial fibrillation (POAF) incidence will be assessed through daily chart review.
次要结局
- Number of participants discontinuing treatment(Through discharge (up to 15 days))
- Change in Liver Function(Baseline and Post operatively (approximately 24 hours))
- Change in creatinine level(Baseline through discharge (up to 15 days))
- Creatine kinase level(Through discharge (up to 15 days))
- Complete blood count (CBC).(Through discharge (up to 15 days))
研究者
Ayesha Ather
Principal Investigator
University of Kentucky